Apparatus and method for monitoring blood glucose levels including convenient display of blood glucose value average and constituent values

ABSTRACT

An effective meal average (EMA) value is presented, followed by two or more of the individual values that make up the EMA, to provide improved feedback data for clinical decisions by patients who need to alter their dose of insulin. The EMA can comprise a measure of the variability of its constituent values, encompass values that occur at specified times such as 1 hour before and after a specified meal time, and be calculated over a limited number of days previous to the calculation (e.g., 3 days) and have a minimum number of values that must be obtained within the time and date ranges. An algorithm can exclude any given reading from the average (e.g., post-prandial or control solution readings). Patients can use 1 to 8 EMA on any given date range (e.g., preferably 4, that is, breakfast, lunch, supper and bedtime snack).

This application is a continuation of U.S. application Ser. No.14/944,786, filed Nov. 18, 2015, which is a continuation of U.S.application Ser. No. 12/457,185, filed Jun. 3, 2009, which is acontinuation of U.S. application Ser. No. 10/658,209, filed Sep. 10,2003, which claims priority from U.S. Provisional Application Ser. No.60/409,965, filed Sep. 11, 2002, the contents of which are expresslyincorporated herein by reference in their entirety.

CROSS-REFERENCE TO RELATED APPLICATIONS

Related subject matter is disclosed in a copending U.S. patentapplication of Gordon et al, entitled “A System and Method forIntegrating Data with Guidelines to Generate Displays Containing theGuidelines and Data”, Ser. No. 09/985,173, filed Nov. 1, 2001; and in aco-pending U.S. patent application of Gordon, entitled “System andMethod for Assessment and Corrective Action Based on Guidelines”, Ser.No. 10/153,883, filed May 24, 2002; the entire contents of allapplications being incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates generally to blood glucose meters and glucosemonitoring for managing diabetes and, more particularly, to presentationof glucose data to a user in a convenient format, including an effectivemeal average and its constituent values and/or a measure of variabilityamong the constituent values.

BACKGROUND OF THE INVENTION

A number of blood glucose monitoring systems are available whichgenerally include a blood glucose meter. The blood glucose meter can beconfigured to receive and read a test strip inserted therein on which adrop of a patient's blood has been deposited, or can be adapted forsubcutaneous readings, for example.

Blood glucose meters generally comprise a memory for storing measuredblood glucose values, along with other data such as the correspondingdates and times of day the values were measured. Blood glucose metersare generally also provided with a display screen, and user inputbuttons with which a user can specify which of the stored values todisplay.

Some blood glucose meters also provide statistical data relating to thestored measured blood glucose values such as 7-day, 14-day and 30-dayaveraging of glucose levels at one or more selected times of day (e.g.,breakfast, lunch, dinner and nighttime). Examples of such blood glucosemeters are Accu-check meters available from Roche Diagnostics USA andOne Touch meters available from LifeScan. These blood glucose meters,however, are disadvantageous because the length of the period of timeover which the averages are calculated is too long when a patient isusing the averaging to adjust his insulin dosage, and particularly whenthe current average blood glucose values are too low.

The Ascensia Dex2 glucose meter available from Bayer Healthcare providesfour daily averages, that is, averages of measured blood glucose valuestaken during a particular period of time such as a two hour windowaround a selected mealtime. No existing blood glucose meter, however,provides an average blood glucose value over a selected bin or period oftime, as well as convenient access to the constituent values used toderive the average value and optionally an indication of variabilityamong the constituent values. As will be described in more detail below,an indication of variability or at least knowledge of constituent valuesused to derive a mealtime average, is important information to have whenadjusting insulin dosage.

Blood glucose monitoring can be combined with a diabetes managementsystem comprising software (e.g., for installation on a personalcomputer (PC) or personal data assistant (PDA)) for collecting andanalyzing meter readings and generating summaries and graphical results(e.g., pie charts, histograms and the like) to assist the patient inunderstanding trends in their blood glucose levels and insulin regimen.These systems, however, also do not provide a patient with immediate andconvenient access to averages of blood glucose levels at a mealtime orduring another specified time period and to the constituent levels usedto generate these averages. For example, the One Touch diabetesmanagement software available from LifeScan can provide mealtimeaverages in a computer generated logbook table; however, the measuredlevels from which the averages were calculated are merely provided by aseparate glucose tracking time table on a different screen. Accordingly,it is not always clear to a patient as to which values are theconstituent values of a particular average. This is disadvantageous whena patient is determining whether an adjustment is needed in his insulindosage. This problem is illustrated by the following hypotheticalsituations.

By way of an example, if a lunchtime average was calculated at 180mg/dl, and the constituent values of the lunchtime average were 162mg/dl, 204 mg/dl and 174 mg/dl, a patient could safely increase thebreakfast dose of a short acting insulin by a small amount since theconstituent values had little variation. If, however, the constituentvalues varied significantly (e.g., were 75 mg/dl, 297 mg/dl and 168mg/dl), the patient could not safely increase the breakfast dose of ashort acting insulin, not even by a small amount. A patient would needto instead decide why there was so much variation, whether it be changesin diet, exercise or stress level. Thus, a need exists for a glucosemonitoring device that provides a patient with convenient and immediateaccess to glucose level averages over relatively short periods of timeand to the constituent values that generated the averages in order tomake meaningful and timely decisions regarding his insulin regimen andother diabetes management techniques.

SUMMARY OF THE INVENTION

In accordance with an aspect of the present invention, a method forannunciating a patient's medical data levels comprises the steps of: (1)calculating an average medical data level from at least a first medicaldata level and a second medical data level selected from the a pluralityof medical data levels and the corresponding dates and times of day therespective medical data levels were taken; (2) annunciating the averagemedical data level; (3) annunciating the first medical data level inresponse to a first user input; and (4) annunciating the second medicaldata level in response to a second user input. The annunciating stepsfor annunciating the average medical data level, the first medical datalevel and the second medical data level, respectively, can be performedby displaying them on a display device, or by generating an audiblesound via a speaker. The medical data levels can be blood glucoselevels. More than two medical data levels can be used, that is, nmedical data levels wherein n is greater than 2.

In accordance with another aspect of the present invention, avariability indicator is provided that indicates the variability betweenthe n medical data levels used to generate the average medical datalevel. The variability indicator is at least one of a scalar value, anda statistical parameter selected from the group consisting of a standarddeviation and a coefficient of variance.

In accordance with yet another aspect of the present invention, theaverage medical data level and the constituent values are displayed on adisplay screen. The display screen comprises a first area for displayingone of the average medical data level and the constituent values, and asecond area configured to have n indicators corresponding to respectiveones of the n medical data levels. Each of the n indicators is displayedas a nonflashing item when the first area is displaying the averagemedical data level. The corresponding one of the n indicators is flashedwhen its corresponding n medical data level is being displayed as one ofthe constituent values. The display screen comprises a third area fordisplaying a time of day and a date for a corresponding one of the nmedical data levels when it is being displayed as a constituent value inthe first area.

In accordance with still yet another aspect of the present invention,calculating the average comprises selecting the medical data levels usedto determine the average medical data level based on the date and timeof day the stored medical data levels were taken. A user can define atime period during a day when the average medical data level is desiredfor that time period on each of a selected number of days (e.g.,preferably three days).

In accordance with an embodiment of the present invention, an apparatusfor patient condition monitoring comprises: (1) an annunciator; (2) auser input device; and (3) a processing device connected to theannunciator and the user input device, provided with at least a subsetof a plurality of medical data levels along with their respective datesand times of day they were taken, and programmable to calculate anaverage medical data level using at least n medical data levels selectedfrom a subset of the plurality of medical data levels that correspond tomedical data levels taken during a selected time period where n is aninteger greater than or equal to 2, the n medical data levels beingconstituent values of the average medical data level, and tosequentially annunciate the average medical data level and respectiveones of the constituent values via said annunciator by, receiving afirst user input from said user input device to annunciate a firstmedical data level from among the constituent values, annunciating thefirst medical data level in response to said first user input, receivinga second user input from said user input device to annunciate a secondmedical data level from among the constituent values, and annunciatingthe second medical data level in response to said second user input. Theannunciator comprises a display device and the average medical datalevel and the constituent values are annunciated using a display screen,said display screen comprising a first area for displaying one valuefrom the group consisting of the average medical data level and theconstituent values, and a second area configured to simultaneouslydisplay n indicators corresponding to respective ones of the n medicaldata levels at least when one of said constituent values is displayed,and said annunciator displays one of said n indicators corresponding tothe constituent value currently being annunciated differently from theother said n indicators in the second area to indicate which of theconstituent values is currently being annunciated.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects, advantages and novel features of the presentinvention will be readily appreciated from the following detaileddescription when read in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of an exemplary blood glucose meter inaccordance with an embodiment of the present invention;

FIG. 2 is a block diagram of the blood glucose meter of FIG. 1;

FIG. 3 depicts a display configuration for a blood glucose meter inaccordance with an embodiment of the present invention;

FIG. 4 is a flow chart depicting a sequence of operations for selectionof effective meal average constituent values in accordance with anembodiment of the present invention;

FIG. 5 is a flow chart depicting a sequence of operations for generatingdisplays to communicate an effective meal average and its constituentvalues in accordance with an embodiment of the present invention; and

FIGS. 6 and 7 illustrate a series of exemplary screens generated by ablood glucose meter in accordance with an embodiment of the presentinvention.

Throughout the drawing figures, like reference numerals will beunderstood to refer to like parts and components.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In accordance with the present invention, a blood glucose meter 100 isprovided with advantageous operations, including the determination anddisplay of an effective mealtime average (EMA) or similar average overanother user-defined period, the convenient and immediate display of theconstituent values used to determine the average, and optionaldetermination and display of variability among the constituent values(e.g., a standard deviation value). The blood glucose meter 100 isexemplified by the Logic™ blood glucose monitor and the Latitude™diabetes management system available from Becton Dickinson and Company.

With reference to FIG. 1, the blood glucose meter 100 of the presentinvention has a blood glucose sensing area 150 for the monitoring ofglucose within a patient. Blood glucose sensing area 150 may utilize avariety of well known means for the monitoring of glucose within apatient. One method may be the use of a disposable strip with reagentsapplied thereto for the sensing of glucose within a bodily fluid. In analternate embodiment of the present invention, sensing area 150 couldutilize well known non-invasive sensing methods for the determination ofglucose within a patient's body. Sensing of glucose by sensing area 150can be intermittent or continuous. Blood glucose meter 100 also can beconfigured to be wearable by the patient.

With reference to FIGS. 1 and 2, blood glucose meter 100 also has aliquid crystal display (LCD) or other type of display device 160 whichcommunicates data within the blood glucose meter 100 to the patientthrough a variety of menus programmed within the software/programinstructions contained within the microprocessor 170 (FIG. 2) of bloodglucose meter 100 or stored in the memory device 190 for execution bythe microprocessor 170. Alternatively, the meter 100 can annunciateblood glucose values and other information audibly via a speechprocessing device and speaker. The memory device 190 can store the bloodglucose values measured by the reader or other sensing device 150, alongwith the dates and times of day they were measured, the stored bloodglucose values that are selected to be constituent values of an average,and calculated values such as the averages and indicators ofvariability, among other information. It is to be understood that othermemory configurations can be used without departing from the scope ofthe present invention.

Blood glucose meter 100 also has a variety of input buttons 110, 120,130 which allow the patient to move through various screens displayed onLCD 160 to view various data within blood glucose meter 100. Forwardbutton 110 and backward button 120 allow patients to move forward andbackward through the menu screens shown on LCD 160. Also shown on bloodglucose meter 100 is a memory button 130 which allows the user to enterthe various menus generated by the software/program instructions ofblood glucose meter 100. At least one input button is required; however,alternate embodiments which contain one or more input buttons withdifferent functions are still within the scope of the present invention.Accordingly, a user input device is indicated generally at 180 in FIG.2.

The present invention provides an advantageous presentation of glucosedata to a person with diabetes from a glucose meter, monitor orcontinuous glucose sensor 100 in which an effective meal average (EMA)value is presented, followed by two or more of the individual values(i.e., hereinafter referred to as the constituent values) that make upthe effective meal average. The effective meal average is comprised ofan average value and its constituent values and/or a measure of thevariability of the range. The effective meal average encompasses thosevalues that occur at specified times (i.e., herein after referred to asthe effective meal average timeframe or EMAT). The EMAT can be, forexample, one hour before and one hour after a specified meal time,although the length of time before and after the meal could be different(e.g., 30 minutes or up to three hours), or during a specified intervalsuch as from 10 AM to 2 PM. The average can also be for a post-mealtimeframe. The effective meal average is calculated over a limitednumber of days that occurred previous to the calculation and ispreferably calculated over three days, although the calculation caninclude as many as 13 days. The EMA has a minimum number of values thatmust be obtained within the time and date ranges, which is preferablythree values, although the EMA can be based on as few as two values oras many values as were measured during the date range. Themicroprocessor 170 also employs an algorithm for excluding any givenreading from the average. For example, patients may not want to includevalues taken after meals (i.e., post-prandial values) or controlsolution readings done during the specified time range. Patients can usefrom one to eight effective meal averages on any given date range, butpreferably use four EMAs determined, for example, for the breakfast,lunch, supper and bedtime snack time periods. The additional fouraverages can be used for post-meal averages and an average in the middleof the night. The effective meal average provides improved feedback datafor clinical decisions by patients with diabetes who use insulin andneed to alter their dose of insulin.

The advantages of the present invention are illustrated by the followingexamples:

Example 1

A Lunchtime EMA is calculated at 180 mg/dl and displayed on the LCD 160.The constituent values of the EMA are 162 mg/dl, 204 mg/dl and 174mg/dl, which are displayed to the patient on the LCD 160 of the bloodglucose meter 100. The EMA and the constituent values are preferablydisplayed via a series of screens, each with a respective one of thevalues, as will be described below in connection with FIGS. 6 and 7. Itis to be understood that displays can be generated with differentgroupings of the EMA and its constituent values and remain within thescope of the present invention. Since the EMA is 180 and the individualvalues have little variation, at 162, 204 and 174, a patient couldsafely increase the breakfast dose of a short acting insulin by a smallamount, for example, 1 unit.

Example 2

A Lunchtime EMA is calculated at 180 mg/dl. The constituent values ofthe EMA are 75 mg/dl, 297 mg/dl and 168 mg/dl which are displayed to thepatient on the LCD 160 of the blood glucose meter 100 preferably via aseries of screens. Since the EMA is 180 and the individual values havesignificant variation, at 75, 297 and 168, a patient could not safelyincrease the breakfast dose of a short acting insulin, even by a smallamount such as 1 unit. A patient could then decide why there is so muchvariation, whether it be changes in diet, exercise or stress level.

Example 3

A Lunchtime EMA is calculated at 180 mg/dl. The constituent values ofthe EMA are 162 mg/dl, 204 mg/dl and 174 mg/dl which are displayed tothe patient on the LCD 160 of the blood glucose meter 100, along with anEMA indicator (e.g., a standard deviation). Since the EMA is 180 and theindividual values have little variation, at 162, 204 and 174, asindicated by the EMA indicator, a patient could safely increase thebreakfast dose of a short acting insulin by a small amount, for example,1 unit.

Example 4

A Lunchtime EMA is calculated at 180 mg/dl. The constituent values ofthe EMA are 75 mg/dl, 297 mg/dl and 168 mg/dl which are displayed to thepatient on the LCD 160 of the blood glucose meter 100, along with an EMAindicator (e.g., a standard deviation). Since the EMA is 180 and theindividual values have great variation, at 75, 297 and 168, as indicatedby the EMA indicator, a patient could not safely increase the breakfastdose of a short acting insulin, even by a small amount such as 1 unit. Apatient could then decide why there is so much variation, whether it bechanges in diet, exercise or stress level.

As indicated by the foregoing examples, in accordance with one aspect ofthe present invention, the EMA is an array which consists of the averageof a series of specific (i.e., with respect to time and other criteria)blood glucose measurements, along with the values which constitute theaverage. In accordance with another embodiment of the present invention,the EMA is an average of a series of specific (i.e., with respect totime and other criteria) blood glucose measurements, along with anindicator of the variability of the specific measurements.

Prior art devices such as the Glucometer DEX2 mentioned in thebackground section above create averages for specific user settabletimes, but do not give the patient any indication of the inherentvariability of the readings within the specific times. The patent isthen unable to make clinical decisions based on the data. The patientonly has an average of the readings of the last 14 days and may make amistake in judgement with respect to the amount of change of insulindosage. By contrast, the present invention advantageously communicatesthe variability dimension of the data. The present invention provides anapparatus and a method to present the data in such a format such thatthe patient has an average of the glucose readings, the constituentvalues used to generate the average, and optionally an indication of thevariability in readings over the period in question (e.g., the effectivemeal average timeframe). Also, in accordance with another advantageousaspect of the present invention, the period of data for review is muchshorter than existing blood glucose monitoring devices, allowing for aclinical judgment which is based on more recent and relevant data,rather than a running average provided by the existing devices.

Reference is now made to FIG. 3, which depicts an illustrative displayconfiguration for LCD or other display device 160 to display an EMA, ora constituent value or other blood glucose measurement data point, asindicated at 340. Also shown on LCD 160 are first indicator block 310,second indicator block 320, and third indicator block 330. Time value350 displays the time of the glucose measurement represented by datavalue 340. A date value can optionally be provided, as indicated at 360.As stated above, it is to be understood that displays can be generatedwith different groupings of the EMA and its constituent values andremain within the scope of the present invention.

With reference to FIGS. 3 and 5, in order to indicate the EMA, indicatorblocks 310, 320, 330 are all displayed and non-flashing. When the firstconstituent value of the EMA is displayed as data value 340, as denotedby box 510 in FIG. 5, the first constituent value's measured time isdisplayed as time value 350, and first indicator block 310 is flashing.When the second constituent value of the EMA is displayed as data value340, as denoted by box 520 in FIG. 5, the second constituent value'smeasured time is displayed as time value 350, and second indicator block320 is flashing. When the third constituent value of the EMA isdisplayed as data value 340, as denoted by box 530 in FIG. 5, the thirdconstituent value's measured time is displayed as time value 350, andthird indicator block 330 is flashing.

FIG. 4 is a flowchart depicting a sequence of operations for theselection of EMA constituent values by the microprocessor 170. Thesoftware/program instructions for the meter 100 enters an EMAcalculation mode. A single data point is read (step 410) from storeddata (step 420) such as data stored in the memory device 190. The storeddata is preferably an array of values representing blood glucosemeasurements, and associated time code information for each measurement,and various other flags. Each data point is compared to criteria (step430) for checking the data point for its suitability for use in aspecific EMA calculation. These criteria can include values and flagscorresponding to specific time frames corresponding to the desired EMAT,date information, calibration check information, post-prandialmeasurement, and specifically user-flagged values, among other criteria.Preferably, in order for the data point to be used as a constituentvalue for the EMA, the data point is within the EMAT, a pre-prandialmeasurement, not a calibration check, and not specifically flagged bythe user. Once a data point is found that meets the criteria in step430, the software/program instructions provide for storing the datapoint (step 440) to a corresponding buffer indicated at 450. The processis repeated (step 460) n times until n EMA constituent values are storedto the constituent value buffer 450, where n can be from 2 to 14, forexample, and more preferably n is 3. When n values have been selected,the microprocessor 170 executing the software/program instructionscalculates population parameters (step 470) of the constituent valueswithin the constituent values buffer 450, and stores the populationparameters (step 480) to a population parameters buffer indicated at490. At a minimum, the population parameters buffer 490 contains theaverage of the constituent values 450. Population parameters buffer 490can additionally contain a standard deviation of the constituent values450 or another statistical parameter (e.g., scalar value, coefficient ofvariance, and the like) which represents the variation of theconstituent values 450.

As shown in FIG. 5, a series of menu screens are preferably displayed byLCD 160 of the blood glucose meter 100. The effective mealtime averageis communicated to the patient via LCD 160. The patient navigates themenus displayed on the LCD 160 by depressing the input buttons110,120,130. The effective meal average screen in FIG. 5 is representedby box 500. Once at the effective meal average screen 500, whichdisplays an average of the readings for the effective meal averagetimeframe, the user can then look at the data values which comprise theeffective meal average by depressing backward button 120 to reacheffective the meal average first constituent value screen denoted by box510. If the user depresses the forward button 110, the LCD 160 displaysthe effective meal average screen 500 again. While on effective mealaverage first value screen 510, if the user depresses backward button120, the LCD 160 displays a effective meal average second constituentvalue screen 520. With another press of backward button 120, the LCD 160displays an effective meal average third constituent value screen 530.With another press of backward button 120, an end marker screen 540 isdisplayed, which indicates to the patient that the last value seen wasthe last value of the EMA. While on end marker screen 540, if the userdepresses backward button 120, LCD 160 reverts to the effective mealaverage screen 500 at which point the patient has seen all constituentvalues from which the effective meal average was derived. Alternatively,this process can be repeated as needed to display any number ofconstituent values. The constituent values can also be displayedsubstantially simultaneously with the average blood glucose level (e.g.,on the same screen), or substantially immediately before and after theaverage blood glucose level using sequential display screens forrespective ones of the average blood glucose level and the constituentvalues that can be generated in a round robin manner.

In accordance with an embodiment of the present invention, effectivemeal average calculation and display are enabled when a Setup.Averagefunction is set to ‘ON’ within the software/program instructions of themeter 100. Four effective meal averages corresponding to four effectivemeal average timeframes are preferably viewed in sequence. Preferably,the time span covered in an effective meal average is defined as thecenter time of that average, plus or minus one hour. For example, amealtime average whose ‘center time’ is 7:15 AM covers blood glucosereadings from 6:15 AM to 8:15 AM. In an alternate embodiment of theinvention, the center time of the effective meal average timeframes issettable by the user.

In accordance with an embodiment of the present invention, each averageis calculated preferably using three readings. One reading is selectedper day and begins with the current day if the current time has alreadyentered or passed the time span for that time block. If the current timehas not yet entered the time span covered in the specified time block(e.g., the EMAT), then the software/program instructions begin with thatsame time span on the previous day. If there is more than one readingwithin the time span on a given day, the software/program instructionsselect the most recent unmarked reading. In an alternative embodiment,the earliest reading is selected. Marked readings are excluded fromaverages such as control solution readings, which are marked with a “C”at 350 (FIG. 3) of the LCD 160, as shown in FIG. 6. Other markedreadings to be excluded (e.g., by choice of the patient) are marked withan “*”. If, on a given day, no readings are found within the time span,the software/program instructions for the meter 100 searches thereadings from the previous day. The software/program instructions goback a maximum of five days from the first and most recent time spansearched. If fewer than three valid readings are found, thesoftware/program instructions control the display device 160 to appearas “---” for that meal time average, indicating that there were notenough readings available to calculate an average from that time block.If there are three valid readings, the meal time average is calculated.

In an alternate embodiment of the invention, the meter 100 can display astandard deviation or other statistical parameter of the EMA data to thepatient to indicate the variability of the average for the effectivemeal average timeframe in question. This indicator of variability ispreferably referred to as an EMA indicator. Such statistical parameterscan be either a standard parameter (e.g., a standard deviation,coefficient of variance, and the like), or a scalar value (e.g., ascaled value from 1 to 10 etc.), which represents the variabilityinherent in the data.

Reference is now made to the exemplary series of display screens on adisplay device 160 depicted in FIGS. 6 and 7. Screen 0.0 depicts thedifferent possible screen areas that are selectively populated withinformation, as illustrated throughout FIGS. 6 and 7, depending on themode selected by the user. The series of display screens indicatedgenerally at 602 in FIG. 6 are for viewing individual blood glucosereadings and are accessed by depressing the memory button 130. Forexample, screen 3.1 is the most recent glucose reading. The forward andbackward keys 110 and 120, respectively, can be used to navigate amongthe most recent readings (e.g., 30 readings) in the memory device 190.These screens comprise “MEM” to indicate that a stored value is beingviewed, the glucose level in units mg/dl, and the date and time of thereading. Screens 3.2 and 3.3 illustrate marked readings that are notused for averaging, as indicated by the “*” and the “C” in theirrespective screens.

The series of display screens indicated generally at 604 in FIG. 6 arefor viewing insulin injections and are preferably only visible wheninsulin is set to be “ON” during set-up of the meter 100. They can beaccessed, for example, by depressing the memory button 130 when thecurrent glucose reading is displayed. The large numerals are indicatedalong with a syringe icon, and alternate between displaying the pennumber and the insulin dose, which is also indicated along with a “U”.The date and time of day of the injection are also indicated.

The memory button 130 can be depressed again to obtain a 7-day averagereading, and depressed again to obtain a 14-day average reading. Screen3.14 provides a 7-day average, and includes the reading in units mg/dland the indication of “7 day”. Screen 3.15 provides a 14-day average,and includes the reading in units mg/dl and the indication of “14 day”.

With reference to FIG. 7, the memory button 130 can be depressed againto obtain a time block average (e.g., an EMA). A first screen 3.16provides a breakfast EMA. The forward and backward keys 110 and 120allow the user to view the constituent values on the screens 3.17through 3.19, which represent valid data taken over the most recentthree days (e.g., February 10, 11 and 12) and during the breakfast EMATfor each day. Another depression of the memory button 130 provides alunchtime EMA screen 3.20. The forward and backward keys 110 and 120allow the user to view the constituent values on the screens 3.21through 3.23, which represent valid data taken over the most recentthree days (e.g., February 9, 10 and 11) and during the lunchtime EMATfor each day. Another depression of the memory button 130 provides adinnertime EMA screen 3.24. The forward and backward keys 110 and 120allow the user to view the constituent values on the screens 3.25through 3.27, which represent valid data taken over the most recentthree days (e.g., February 9, 11 and 12) and during the dinnertime EMATfor each day. As stated above, if no valid data is available for thedinnertime EMAT on a given day (e.g., February 10), then themicroprocessor 170 is programmed to use data from the previous day,February 9. Finally, another depression of the memory button 130provides a nighttime EMA screen 3.28. The forward and backward keys 110and 120 allow the user to view the constituent values on the screens3.29 through 3.31, which represent valid data taken over the most recentthree days (e.g., February 8, 10 and 12) and during the nighttime EMATfor each day.

It is to be understood that the toggling between viewing modes (e.g.,individual blood glucose readings, insulin injection readings, 7-dayaverage reading, 14-day average reading, and time block averages (e.g.,EMAs) by depressing the memory button can be ordered differently thanshown in FIGS. 6 and 7, or include more or fewer information viewingmodes. Further, the meter 100 can be provided with different userbuttons or other input devices that allow direct access to any of theinformation viewing modes (e.g., selection from a menu of informationdisplay options provided on the LCD 160).

The following represents exemplary code for implementing an embodimentof the present invention.

1.1.1 Meal Time Average Button Functions

1.1.1.1 static DisplayMealBars(void)

This function displays meal bar annunciators.

Turn ON meal bar 1, 2 and 3 annunciators

If record counter=1

-   -   Enable flashing for meal bar 1 annunciator    -   Disable flashing for meal bar 2 annunciator    -   Disable flashing for meal bar 3 annunciator

Else if record counter=2

-   -   Disable flashing for meal bar 1 annunciator    -   Enable flashing for meal bar 2 annunciator    -   Disable flashing for meal bar 3 annunciator

Else if record counter=3

-   -   Disable flashing for meal bar 1 annunciator    -   Disable flashing for meal bar 2 annunciator    -   Enable flashing for meal bar 3 annunciator        1.1.1.2 static void M_UiMealTimeAverage(TBNum)    -   This function displays the Time Block's center time and average.        If the average cannot be calculated, the meter displays ‘---’.    -   Input: TBNum, time block number    -   Display Setup.CTime[TBNum].Hours    -   Display Setup.CTime[TBNum].Minutes    -   Call IntervalAverage routine, to calculate time block average    -   If IntervalAverage result<0 Display ‘---’    -   Else        -   Display IntervalAverage result        -   Clear record counter        -   Call DisplayMealBars, to display meal bar annunciators            1.1.1.3 static void LUiMealThneAverage(TBNum)    -   This function displays an older glucose record used for        averaging or the time block average. If the average cannot be        calculated, the meter displays ‘---’.

Action Current Display Next Display Left arrow Button ‘---’ (Can'tcalculate average) No change press Time Block Average Glucose Record No.1 Glucose Record No. 1 Glucose Record No. 2 Glucose Record No. 2 GlucoseRecord No. 3 Glucose Record No. 3 ‘End’ ‘End’ Time Block Average

-   -   Input: TBNum, time block number    -   If IntervalAverage result>0        -   Increment record counter        -   Clear display        -   If record counter>4            -   Clear record counter            -   Display Setup.CTime[TBNum].Hours            -   Display Setup.CTime[TBNum].Minutes            -   Display IntervalAverage result            -   Call DisplayMealBars, to display meal bar annunciators        -   Else if record counter=4            -   Display ‘End’        -   Else            -   Display glucose record indexed by the record counter            -   Call DisplayMealBars, to display meal bar annunciators                1.1.1.4 static void_RUiMealThneAverage(1′BNum)    -   This function displays a newer glucose record used for averaging        or the time block average. If the average cannot be calculated,        the meter displays ‘---’.

Action Current Display Next Display Right arrow ‘---’ (Can't calculateaverage) No change Button press Time Block Average No change GlucoseRecord No. 1 Time Block Average Glucose Record No. 2 Glucose Record No.1 Glucose Record No. 3 Glucose Record No. 2 ‘End’ Glucose Record No. 3

-   -   -   Input: TBNum, time block number

    -   If IntervalAverage result>0        -   Decrement record counter        -   If record counter<1            -   Clear record counter            -   Display Setup.CTime[TBNum].Hours            -   Display Setup.CTime[TBNum].Minutes            -   Display IntervalAverage result        -   Else            -   Display glucose record indexed by the record counter            -   Call DisplayMealBars, to display meal bar annunciators

1.1.2 A1 Time Block Average

-   -   The meter enters this state when Setup.Average is ON, the meter        is in the 14-day Average state and the user held the Mode button        less than 1.5 seconds.

1.1.2.1 Static Void MUiMealTime1Average(Void)

-   -   If Set-up.Average is ON, this function displays the time block        average. If the average cannot be calculated, the meter displays        ‘---’. If Setup.Average is OFF, this function resets the state        machine to the Individual Glucose Reading Review state.    -   Global Parameters used:        -   Setup.Average    -   If Setup.Average is ON        -   Call M_UiMealTimeAverage(0), to calculate and display block            average    -   Else        -   UiState=kState1        -   Call M UiRecallResults, back to Individual Blood Glucose            Readings

1.1.2.2 Static Void L_UiMealTime1Average(Void)

-   -   This function displays an older glucose record used for        averaging or the time block average. If the average cannot be        calculated, the meter displays ‘---’.    -   Call L UiMealTimeAverage(0), to display older averaging glucose        record

1.1.2.3 Static Void R_UiMealTime1Average(Void)

-   -   This function displays a newer glucose record used for averaging        or the time block average. If the average cannot be calculated,        the meter displays ‘---’.    -   Call R_UiMealTimeAverage(0), to display newer averaging glucose        record

1.1.3 A2 Time Block Average

The meter enters this state when the meter is in the A1 Time BlockAverage state and the user held the Mode button less than 1.5 seconds.

1.1.3.1 Static Void M_UiMealTime2Average(Void)

-   -   This function displays the time block average. If the average        cannot be calculated, the meter displays ‘---’.    -   Call M_UiMealTimeAverage(1), to calculate and display block        average

1.1.3.2 Static Void L_UiMealTime2Average(Void)

-   -   This function displays an older glucose record used for        averaging or the time block average. If the average cannot be        calculated, the meter displays ‘--’.    -   Call L_UiMealTimeAverage(1), to display older averaging glucose        record

1.1.3.3 Static Void R_UiMealTime2Average(Void)

-   -   This function displays a newer glucose record used for averaging        or the time block average. If the average cannot be calculated,        the meter displays ‘---’.    -   Call R_UiMealTimeAverage(1), to display newer averaging glucose        record

1.1.4 A3 Time Block Average

-   -   The meter enters this state when the meter is in the A2 Time        Block Average state and the user held the Mode button less than        1.5 seconds.

1.1.4.1 Static Void MUiMealTime3Average(Void)

-   -   This function displays the time block average. If the average        cannot be calculated, the meter displays ‘---’.    -   Call M_UiMealTimeAverage(2), to calculate and display block        average

1.1.4.2 Static Void L_UiMealTime3Average(Void)

-   -   This function displays an older glucose record used for        averaging or the time block average. If the average cannot be        calculated, the meter displays ‘---’.    -   Call L_UiMealTimeAverage(2), to display older averaging glucose        record

1.1.4.3 Static Void R_UiMealTime3Average(Void)

-   -   This function displays a newer glucose record used for averaging        or the time block average. If the average cannot be calculated,        the meter displays ‘---’.    -   Call R_UiMealTimeAverage(2), to display newer averaging glucose        record

1.1.5 A4 Time Block Average

-   -   The meter enters this state when the meter is in the A3 Time        Block Average state and the user held the Mode button less than        1.5 seconds. In this state, if the Mode button is held less than        1.5 seconds, the state machine resets to the Individual Blood        Glucose Results Review state.

1.1.5.1 Static Void M_UiMealTime4Average(Void)

-   -   This function displays the time block average. If the average        cannot be calculated, the meter displays ‘---’.    -   Call M_UiMealTimeAverage(3), to calculate and display block        average

1.1.5.2 Static Void L_UiMealTime4Average(Void)

-   -   This function displays an older glucose record used for        averaging or the time block average. If the average cannot be        calculated, the meter displays ‘---’.    -   Call LUiMealTimeAverage(3), to display older averaging glucose        record

1.1.5.3 Static Void R_UiMealTime4Average(Void)

-   -   This function displays a newer glucose record used for averaging        or the time block average. If the average cannot be calculated,        the meter displays ‘---’.    -   Call R_UiMealTimeAverage(3), to display newer averaging glucose        record

Although the present invention has been described with reference topreferred embodiments thereof, it will be understood that the inventionis not limited to the details thereof. Various modifications andsubstitutions will occur to those of ordinary skill in the art. All suchsubstitutions are intended to be embraced within the scope of theinvention as defined in the appended claims.

1. A method of annunciating a patient's medical data levels comprising the steps of: selecting a time period and a corresponding subset of a plurality of medical data levels comprising medical data levels taken during the time period and storing at least the subset of medical data levels in a memory device; calculating using a processing device an average medical data level using at least n stored medical data levels selected from the subset of stored medical data levels where n is an integer greater than or equal to 2, the n stored medical data levels being constituent values of said average medical data level; sequentially annunciating said average medical data level and respective ones of the constituent values comprising annunciating said average medical data level, annunciating a first medical data level in response to first user input to annunciate said first medical data level from among the constituent values, and annunciating a second medical data level in response to a second user input annunciate said second medical data level from among the constituent values; wherein each of the annunciating steps comprises displaying a corresponding one of said average medical data level and said constituent values on a display screen, the display screen comprising a first area for displaying one value selected from the group consisting of the average medical data level and said constituent values, and second area configured to simultaneously display n indicators corresponding to respective ones of said n stored medical data levels at least when one of said constituent values is displayed, and the annunciating steps for displaying said constituent values comprises displaying one of said n indicators corresponding to the constituent value currently being annunciated differently from the other ones of said n indicators in the second area to indicate which of said constituent values is currently being annunciated.
 2. A method as claimed in claim 1, wherein each of the three said annunciating steps for annunciating said average medical data level, said first medical data level and said second medical data level, respectively, can be accompanied by generating a corresponding audible signal via a speaker.
 3. A method as claimed in claim 1, wherein the medical data levels are blood glucose levels and the medical data levels are provided by a blood glucose meter.
 4. A method as claimed in claim 1, further comprising the step of annunciating a variability indicator that indicates the variability between said n stored medical data levels by at least one of displaying said variability indicator on the display screen and generating a corresponding audible signal via a speaker.
 5. A method as claimed in claim 4, wherein said variability indicator is at least one of a scalar value, and a statistical parameter selected from the group consisting of a standard deviation and a coefficient of variance.
 6. A method as claimed in claim 1, further comprising the steps of: annunciating a next medical data level in response to another user input to annunciate the next medical data level among said n stored medical data levels after said first medical data level and said second medical data level; and repeating annunciating the next medical data level in response to another user input to annunciate the next medical data level among the n medical data levels until each of said constituent values have been annunciated.
 7. A method as claimed in claim 6, wherein said repeating step comprises the step of annunciating the average medical data level after the last medical data level among said constituent values has been annunciated.
 8. A method as claimed in claim 1, further comprising the step of displaying each of said n indicators as nonflashing items when said first area is displaying said average medical data level, and flashing the corresponding one of said n indicators when its corresponding n medical data level is being displayed as one of the constituent values.
 9. A method as claimed in claim 1, wherein said display screen comprises a third area for displaying a time of day and a date, and further comprising the step of displaying the time of day and date stored with a corresponding one of said n stored medical data levels in said third area when it is being displayed as a constituent value in said first area.
 10. A method as claimed in claim 1, wherein said calculating step comprises the step of selecting the n stored medical data levels used to determine said average medical data level based on the date and time of day the stored medical data levels were taken.
 11. A method as claimed in claim 10, wherein the time period is a period of time during a day, the subset of stored medical data levels comprises stored medical data levels taken during the period of time on a selected number of days, and said calculating step further comprises calculating the average medical data level for that time period over the selected number of days.
 12. A method of displaying blood glucose levels comprising the steps of: selecting a time period and a corresponding subset of a plurality of blood glucose levels comprising blood glucose levels taken during the time period and storing at least the subset of the medical data levels in a memory device; calculating using a processing device an average blood glucose level from at least three of the subset of stored blood glucose levels as the constituent values of the average blood glucose level; sequentially displaying the average blood glucose level using a display device and respective ones of the constituent values comprising displaying said average blood glucose level, displaying a first one of the constituent values in response to a first user input to display the first one of the constituent values, displaying a second one of the constituent values in response to a second user input to display the second one of the constituent values, displaying a third one of the constituent values in response to a third user input to display the third one of the constituent values, and displaying the average blood glucose level again in response to another user input to display a value; wherein each of the displaying steps comprises displaying said average blood glucose level and the constituent values on a display screen, the display screen comprising a first area for displaying one value selected from the group consisting of the average blood glucose level and the constituent values, and a second area configured to simultaneously display three indicators corresponding to respective ones of the three constituent values at least when one of said constituent values is displayed, and the displaying steps for displaying the constituent values comprise displaying one of the three indicators corresponding to the constituent value currently being displayed in the first area differently from the other ones of the three indicators in the second area to indicate which of the constituent values is currently being displayed.
 13. A method as claimed in claim 12, wherein display screen is on a display device that comprises forward and backward arrow keys for navigation forward and backward, respectively, among the different displayed constituent values.
 14. A method as claimed in claim 12, further comprising the step of displaying each of said three indicators as nonflashing items when said first area is displaying the average blood glucose level, and flashing the corresponding one of said three indicators when its corresponding constituent value is being displayed.
 15. A method as claimed in claim 12, wherein said calculating step comprises the step of selecting the stored blood glucose levels used to determine said average blood glucose level based on the date and time of day the stored blood glucose levels were taken.
 16. A method as claimed in claim 12, wherein said calculating step further comprises selecting the time period to be a period of time during a day, the subset of stored medical data levels comprises stored medical data levels taken during the period of time on a selected number of days, and calculating the average blood glucose level for that time period over the selected number of days.
 17. An apparatus for patient condition monitoring comprising: an annunciator; a user input device; and a processing device connected to said annunciator and said user input device, provided with at least a subset of a plurality of medical data levels along with their respective dates and times of day they were taken, and programmed to calculate an average medical data level using at least n medical data levels selected from a subset of the plurality of medical data levels that correspond to medical data levels taken during a selected time period where n is an integer greater than or equal to 2, the n medical data levels being constituent values of the average medical data level, and to sequentially annunciate the average medical data level and respective ones of the constituent values via said annunciator by, receiving a first user input from said user input device to annunciate a first medical data level from among the constituent values, annunciating the first medical data level in response to said first user input, receiving a second user input from said user input device to annunciate a second medical data level from among the constituent values, and annunciating the second medical data level in response to said second user input; wherein said annunciator comprises a display device and the average medical data level and the constituent values are annunciated using a display screen, said display screen comprising a first area for displaying one value from the group consisting of the average medical data level and the constituent values, and a second area configured to simultaneously display n indicators corresponding to respective ones of the n medical data levels at least when one of said constituent values is displayed, and said annunciator displays one of said n indicators corresponding to the constituent value currently being annunciated differently from the other said n indicators in the second area to indicate which of the constituent values is currently being annunciated.
 18. An apparatus as claimed in claim 17, wherein said annunciator is at least one of the display device and a speaker, and said processing device is operable to annunciate by at least one of displaying on said display screen, and generating a corresponding audible signal via said speaker.
 19. An apparatus as claimed in claim 17, wherein the medical data levels are blood glucose levels.
 20. An apparatus as claimed in claim 17, wherein said processing device is programmable to determine and annunciate a variability indicator via said annunciator that indicates the variability between the n medical data levels by at least one of displaying said variability indicator on the display screen and generating a corresponding audible signal via a speaker.
 21. An apparatus as claimed in claim 17, wherein the variability indicator is at least one of a scalar value, and a statistical parameter selected from the group consisting of a standard deviation and a coefficient of variance.
 22. An apparatus as claimed in claim 17, wherein said processing device is programmed to display each of said n indicators as nonflashing items when said first area is displaying the average medical data level, and flash the corresponding one of said n indicators when its corresponding n medical data level is being displayed as one of the constituent values.
 23. An apparatus as claimed in claim 17, wherein said display screen comprises a third area for displaying a time of day and a date, said processing device being further programmed to display the time of day and date of a corresponding one of the n medical data levels in said third area when it is being displayed as a constituent value in said first area.
 24. An apparatus as claimed in claim 17, wherein said processing device is programmable to select the n medical data levels used to determine said average medical data level based on the date and time of day the medical data levels were taken.
 25. An apparatus as claimed in claim 17, wherein said user input device comprises forward and backward arrow keys for navigation forward and backward, respectively, among the annunciated said constituent values. 